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NDC 70000-0066-01 Acetaminophen, Aspirin, Caffeine 250; 250; 65 mg/1; mg/1; mg/1 Details

Acetaminophen, Aspirin, Caffeine 250; 250; 65 mg/1; mg/1; mg/1

Acetaminophen, Aspirin, Caffeine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.

Product Information

NDC	70000-0066
Product ID	70000-0066_c4fcfaa7-996d-7aaa-e053-2995a90a61de
Associated GPIs	64990003200350
GCN Sequence Number	040186
GCN Sequence Number Description	aspirin/acetaminophen/caffeine TABLET 250-250-65 ORAL
HIC3	H3D
HIC3 Description	ANALGESIC/ANTIPYRETICS, SALICYLATES
GCN	10414
HICL Sequence Number	001807
HICL Sequence Number Description	ASPIRIN/ACETAMINOPHEN/CAFFEINE
Brand/Generic	Generic
Proprietary Name	Acetaminophen, Aspirin, Caffeine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Aspirin, Caffeine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	250; 250; 65
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; ASPIRIN; CAFFEINE
Labeler Name	Cardinal Health
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0066-01 (70000006601)

Pricing Information
NDC Package Code	70000-0066-1
Billing NDC	70000006601
Package	1 BOTTLE in 1 CARTON (70000-0066-1) / 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2020-11-06
NDC Exclude Flag	N
Price Per Unit	0.06567
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	HEADACHE RLF 250-250-65 MG CPLT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b3773f02-02a9-33c8-e053-2995a90a2235 Details

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

SPL UNCLASSIFIED SECTION

Purposes

Pain reliever

Pain reliever aid

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ a cold

■ arthritis

■ toothache

■ premenstrual and menstrual cramps

SPL UNCLASSIFIED SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ take more or for a longer time than directed ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

■ you have liver disease

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ have bloody or black stools ■ vomit blood

■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.

■ ringing in the ears or loss of hearing occurs

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ painful area is red or swollen

■ any new symptoms appear.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years and over:

■ take 2 caplets every 6 hours

■ do not take more than 8 caplets in 24 hours

■ children under 12 years: ask a doctor

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

SPL UNCLASSIFIED SECTION

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin® Extra Strength.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

1-800-200-6313

www.myleader.com

PRINCIPAL DISPLAY PANEL

Leader

NDC 70000-0066-1

Extra Strength

Headache Relief

Acetaminophen

Aspirin (NSAID)*/Caffeine

Pain Reliever/Pain Reliever Aid

COMPARE TO EXCEDRIN® EXTRA STRENGTH active ingredients†

100 Caplets

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, ASPIRIN, CAFFEINE

acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0066
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYDEXTROSE (UNII: VH2XOU12IE)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
POVIDONE K30 (UNII: U725QWY32X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	2793
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0066-1	1 in 1 CARTON	11/06/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/06/2020

Labeler - Cardinal Health (063997360)

Revised: 6/2021

Document Id: c4fcfaa7-996d-7aaa-e053-2995a90a61de

Set id: b3773f02-02a9-33c8-e053-2995a90a2235

Version: 2

Effective Time: 20210617

Search by Drug Name or NDC

NDC 70000-0066-01 Acetaminophen, Aspirin, Caffeine 250; 250; 65 mg/1; mg/1; mg/1 Details

Acetaminophen, Aspirin, Caffeine 250; 250; 65 mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 70000-0066-01 (70000006601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b3773f02-02a9-33c8-e053-2995a90a2235 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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